BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR S

    MDR report key: 22798017 · Received August 13, 2025

    Report

    Report Number
    1028232-2025-03978
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 21, 2025
    Report Date
    March 23, 2026
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN BASED ON AVAILABLE INFORMATION AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE DEVICE WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. WITHIN THIS ANALYSIS THE DEVICE WAS VISUALLY, MECHANICALLY AND FUNCTIONALLY INSPECTED. THE VISUAL AND MECHANICAL INSPECTION REVEALED THAT THE INFUSION HANGER ARM OF THE REOCOR WAS BROKEN. IN ADDITION, THE BACKSIDE COVER, THE SCREW BEARING AND THE BATTERY COMPARTMENT ARE DAMAGED. THE REDEL ADAPTER RETURNED WITH THE REOCOR SHOWED A DAMAGED HOUSING. DURING THE FUNCTIONAL ANALYSIS THE OBSERVATION COULD NOT BE CONFIRMED AS THE EXTERNAL PACEMAKER COULD NOT BE SWITCHED ON. A DETAILED TECHNICAL ANALYSIS HAS REVEALED THAT THE REOCOR HAS ALREADY BEEN OPENED BY THE CUSTOMER. THE MAIN CIRCUIT BOARD SHOWS SIGNS OF IMPROPER SOLDERING, RESULTING IN DAMAGE TO ELECTRONIC COMPONENTS. IN ADDITION, FOLLOWING THE IMPROPER SOLDERING, THE DEVICE WAS REASSEMBLED INCORRECTLY, WHICH CAUSED DAMAGE TO THE INTERNAL WIRING. DUE TO THE UNAUTHORISED MODIFICATION, THE DEVICE CANNOT BE REPAIRED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES.

    Description of Event or Problem · 0

    THE DEVICE HAS FAILED BECAUSE THE IMPEDANCE EXCEEDED THE ANTICIPATED LIMIT, TRIGGERING AN ALARM. PROLONGED SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79326 REOCOR S EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization